What are the responsibilities and job description for the Quality Lead – GxP Data Integrity & Compliance position at Grove Technical Resources, INC?
Job Title: Quality Lead – GxP Data Integrity & Compliance - Pharmaceutical
Location: Boston, MA (Hybrid, 3 days onsite per week)
Duration: 6 months (with potential extension)
Type: W2/C2C.
Seeking an experienced Quality Lead to provide GxP data integrity and technology oversight for lifecycle activities in the pharmaceutical industry. This role involves CSV documentation, electronic data integrity compliance, quality risk management, and governance of computerized systems.
Key Responsibilities:
Facilitate data integrity reviews and risk assessments for business processes
Author, review, and approve CSV lifecycle documents for standalone manufacturing/analytical systems
Act as a Strategic Quality Lead for GxP computerized system lifecycle (SLC) activities
Manage and facilitate data mapping initiatives and process/data flow development
Provide business analysis support, process documentation, and compliance assessments
Oversee electronic data integrity guidance for GxP systems
Identify and drive continuous improvement initiatives.
Required Skills & Experience:
10 years of experience in computerized systems validation (CSV) in Pharma/Biotech
Strong knowledge of 21 CFR Part 11, Data Integrity Compliance, and GAMP 5
Experience in GxP system lifecycle, risk management, and regulatory compliance
Excellent project management, problem-solving, and communication skills
Preferred:
Bachelor's degree in Computer Science, Information Management, or STEM
Certified Quality Auditor (ASQ) or Certified Data Integrity Manager
Ability to travel up to 25% of the time (domestic and international).
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